Disclosing Medical Errors Best Practices from the “Leading Edge”

The answer to the question, “What is being done to turn the tide?” is, at least, twofold: first, patients and family members who have been harmed through medical errors are demanding to

This paper was contracted by the Robert Wood Johnson Foundation Preliminary interviews were

conducted in support of the workshop entitled, “Disclosure: What’s Morally Right Is Organizationally Right,” at the 18th Annual IHI National Forum on Quality Improvement in Health Care, December 10-13,

2006, Orlando, Florida, USA For more information, contact Eve Shapiro, Medical Writer, at

eveshapiro@aol.com.

Disclosing Medical Errors: Best Practices from the “Leading Edge”

By Eve Shapiro

Introduction

Mary McClinton went into Virginia Mason Medical Center for a relatively routine

procedure in 2004 While there she died after receiving an injection of chlorhexidine, a caustic cleaning solution, instead of normal saline Both were clear liquids and had been placed side by side in unlabelled cups in the operating room

A 9-year-old girl who had just undergone surgery at the University of Michigan Health System in 2001 gave herself a lethal dose of dilaudid because she was given a

miscalibrated PCA pump

Betsey Lehman, a Boston Globe reporter, and Maureen Bateman were being treated for

breast cancer at the Dana-Farber Cancer Institute in late November 1994 Lehman died

on December 3 and Bateman suffered permanent heart damage because, in one day, they received four times the daily dose of the anticancer drug cyclophosphamide

In 1999, the Institute of Medicine shocked the nation by reporting that between 44,000

and 98,000 people die in hospitals each year as a result of medical errors That report, To Err Is Human,1 raised awareness about the prevalence of medical errors in our nation’s hospitals Six years later, in 2006, the Institute of Medicine released the report,

Preventing Medication Errors,2 which revealed that a hospitalized patient can expect to

experience, on average, one medication error per day

Dr Donald Berwick, president of the Institute for Healthcare Improvement, experienced such errors himself when his wife was a patient in a well-known Boston hospital “It was

not just how she was treated,” Berwick told Time magazine,3 “it was that so little of what happened to her was unusual.” Despite Berwick’s best efforts on his wife’s behalf, he says, “tests were repeated unnecessarily, data were misread, information was misplaced Things weren’t just slipping through the cracks; the cracks were so big there was no solidground.”

The prevalence of medical errors and their impact on the lives of patients and their families is profound Why, eight years after the IOM issued its indictment of the health

1 Institute of Medicine To Err Is Human: Building a Safer Health Care System Washington, DC: National

Academies Press; 1999.

2 Institute of Medicine Preventing Medication Errors Washington, DC: National Academies Press, 2006.

3 Gibbs N, Bower A Q: What Scares Doctors? A: Being the Patient Time, April 23, 2006.

care system challenging it to reduce medical errors, are errors still a common fact of life

in our nation’s hospitals? What is being done to turn the tide?

The answer to the question “why” medical errors are still taking place may lie in the IOM’s recognition that medical errors are not usually the fault of a single person

delivering health care The problem, the report pointed out, instead has more to do with flawed systems So, for example, if a hospital’s practice is to pour solutions that look alike into clear cups before an operation without clearly distinguishing one from another,

an error is almost inevitable It would be easy for someone to reach for the wrong cup without realizing it Preventing such an error would require not punishing the person whoreached for the wrong cup, but changing the way the hospital prepares liquids before surgery Doing so would be considered a systems change

Changing systems is more complex than punishing a person who makes an error But, ultimately, fixing flaws in the system is the only way to prevent the same errors from happening over and over again Medical institutions have been slow to change their systems because doing so requires at least three things: first, admitting that errors are made; second, communicating the errors to patients and families, throughout the

institution and, often, to the media; and third, suffering the uncertain consequences of an error’s disclosure, which are commonly thought to include malpractice lawsuits

The answer to the question, “What is being done to turn the tide?” is, at least, twofold: first, patients and family members who have been harmed through medical errors are demanding to be told the truth when something goes wrong in their care; and second, some medical institutions, such as the Harvard Hospitals, are promoting open

communication, full disclosure of medical errors, and apologies to patients and their families when something goes wrong.4

Patients and families have banded together to push for full disclosure of medical errors, along with apologies, by establishing patient advocacy groups Grass-roots organizations such as Sorry Works! (sorryworks.net), Patients United Limiting Substandards and Errors

in Healthcare (PULSE), Medically Induced Trauma Support Services (MITTS),

Consumers Advancing Patient Safety (CAPS), and others are raising the awareness of political leaders, legislators, and the medical community about the urgent need for

change

Some medical institutions are seeking to turn the tide of medical errors by doing what medical institutions have been historically afraid to do: that is, to confront and openly admit their mistakes, to disclose them to patients and families and throughout their institutions, to investigate their causes, and to use what they learn to improve their

processes and their systems so these errors do not recur The seven organizations

highlighted here have begun this journey What they’re doing, how they’re doing it, and what they’re learning in the process is the subject of this white paper

4 Harvard Hospitals When Things Go Wrong: Responding to Adverse Events A Consensus Statement of the

Harvard Hospitals Burlington, Massachusetts: Massachusetts Coalition for the Prevention of Medical Error; March 2006.

University of Illinois Medical Center

Nikki Centomani, R.N., Director, Department of Safety and Risk Management at the University of Illinois Medical Center, has long believed that confronting and openly disclosing medical errors as soon as they are discovered is the right thing to do for severalreasons First, open disclosure is the most effective way to reduce errors because it beginsthe process of learning Second, open disclosure begins the process of healing for all involved: for patients, families, and health care providers Third, she intuited, open disclosure would lead to fewer, rather than more, lawsuits Bolstered by these beliefs, Centomani began in 2002 what would be a four-year campaign to convince hospital administrators and leaders to adopt a policy of full disclosure

What made this a four-year effort instead of something much shorter was fear, according

to Timothy McDonald, M.D., J.D., Associate Professor in the Department of

Anesthesiology “The hospital’s defense bar and claims management lawyers resisted for years,” McDonald says, “advising the hospital and its physicians to ‘deny, deny, deny,’ even in such cases as wrong-site surgery.” As McDonald describes it, their own defense lawyers were the biggest barriers of all “We had one horrendous sentinel event and I pushed for full disclosure,” McDonald recalls “We’d done a wrong site surgery in a neurosurgery case Nikki and the physician said, ‘Isn’t this a case where we should just tell the family we made a mistake and settle it instead of it letting it become a lawsuit?’” The answer was “No,” McDonald relates, because there was no institution-wide process

in place to disclose an error

What finally convinced the leadership at the University of Illinois Medical Center to adopt a policy of full disclosure in 2006? As McDonald explains, it was a combination of Centomani’s persistence and a little luck

First, an Attitude Shift

The luck came in the form of shifting personnel New people came in on the business side who had heard about the positive outcomes of the full disclosure policies at the University of Michigan and the Lexington, Kentucky, Veterans Administration The new staff members took those results seriously and, McDonald recalls, thought it would be worth considering a process for full disclosure

“When we decided to establish a policy and process for disclosure, we interviewed 16 law firms,” says McDonald “Twelve of the 16 told us that medical errors should not be disclosed and advised us to continue denying errors when they occurred Four of the firms approved of full disclosure These are the four we chose to represent us,” he says Then, in 2005, McDonald and colleagues spent two and a half days in Ann Arbor with Rick Boothman, learning about the University of Michigan policy, process, and

experience in fully disclosing medical errors to patients and families When they returned

to Illinois, McDonald says, they set out to develop their own process

The Process

McDonald and colleagues developed a process for disclosing medical errors to be

followed by everyone within the University of Illinois Medical Center every time an erroroccurs The process begins at the point an error is discovered and ends at the point, McDonald says, “the organization has assured itself that the likelihood of it occurring again is nil From top to bottom,” he says, “that is what we did.”

According to the process, an investigation begins to determine whether a further

investigation is warranted as soon as an error is discovered If it is, the process follows steps outlined by McDonald:

 If it’s a probable error, a rapid investigation team determines whether it’s a clear error

 If it’s a clear error, the case meets our criteria for an apology with full disclosure

 If an apology is delivered with full disclosure, the remedy (that is, compensation)

is considered

 If a remedy is offered, a liaison is created between the patient and family and the claims department, since physicians and nurses shouldn’t manage the process of financial compensation for medical errors

 If a claim is large, the organization must decide how the claim will travel through the administrative approval process

 Contemporaneous with the steps involving remedy, the organization must decide how to put process improvements in place to prevent future error

Developing the process was only the beginning Next, McDonald and colleagues would have to convince others that disclosing medical errors using this process was the right thing to do, both ethically and financially

The Right Thing to Do

“Slowly but surely, we started meeting with all the stakeholders whose buy-in we

needed,” McDonald says “These were everyone in the organization from top to bottom: the president of the university, then the chancellor, the provost, the dean of the college of medicine, the chief executive officer of the health care system, the chief medical officer, and the chief nursing officer We then vetted the process through the board of trustees Wedrilled down to the grass roots,” he says Next, McDonald and his colleagues held small group meetings throughout the medical center to explain the process and to highlight the positive experiences of the University of Michigan Health System and the Lexington, Kentucky, VA in disclosing medical errors

“Then,” McDonald says, “we pushed for transparency by stating the following concepts:

 “We are not just providing full disclosure and rapid settlement; we’re taking each

of these cases and learning from it

 “The way we’re going to successfully manage the medical malpractice crisis is through safer care, not tort reform

 “The best risk management strategy is patient safety

 “One important way to improve patient safety is to not make the same mistakes over and over again.”

“At the end of one of our presentations on patient safety and full disclosure,” McDonald recalls, “the president of the university, B Joseph White, looked at us and said, ‘At the end of the day, isn’t it just the right thing to do?’”

McDonald and his colleagues adopted the president’s words and combined them with the principles Rick Boothman followed at the University of Michigan Health System:

 When we hurt someone through unreasonable medical care, we need to make it right

 When the care our staff provides is reasonable, we need to support them even when something goes wrong

 We need to learn something from medical errors that will help us to improve our care

Their next step, McDonald says, would be to help their physicians put the policy and process into practice

Training and Consultation

McDonald and his colleagues knew that disclosing medical errors doesn’t come easily to all clinicians Some are better natural communicators than others, but training for

everyone would be essential The type of training they decided to provide was twofold: first, classroom training given by Gerald Hickson, M.D., associate dean for Clinical Affairs and director of the Center for Patient and Professional Advocacy, Vanderbilt University Medical Center; and then, on-the-spot training available whenever something goes wrong They called this on-the-spot training their Patient Communication Consult Service

The telephone number for the Patient Communication Consult Service hotline is posted all over the organization and it works this way, as McDonald explains: “Anytime there’s

an adverse event of any kind, clinicians can call a hotline 24 hours a day, seven days a week Whoever is carrying a pager in the office of safety and risk management will get animmediate page and be notified that someone in the organization has been involved in an adverse event and needs help talking to patients and families It may or may not involve aclear error If it appears to be a clear error, we prepare the possibility of a remedy If the case does not involve a medical error, we give the clinician advice, based on our level of experience and training, on communicating with patients.”

“To create the communication consult service we hand-picked people we wanted to train

in all our departments, including medicine, nursing, pharmacy, guest services,

administration, legal, and so on,” McDonald continues “This was a ‘train the trainer’ process, whereby the people we trained went back and trained other personnel in their departments.”

Spreading the Word

Putting a process in place to disclose medical errors would be effective only if everyone

in the organization were familiar with the process and would follow it “We held a huge symposium on the full disclosure process that was open to the entire hospital,” McDonaldrecalls, “which 110 people attended.” But staff awareness requires more; it requires continual reinforcement “We have monthly symposia where issues related to full

disclosure and communication come up, where we can talk about big wins and losses, what went well and what didn’t We created a form on which the staff can evaluate the effectiveness of full disclosure with patients and families, and we discuss these at the monthly group meetings,” McDonald says

“We also hold seminars with the ethics department on the second victim,” McDonald continues, “the person who has made the error, to discuss how badly they feel and what the impact the error may be Putting in a system where there’s employee assistance for everyone is important.”

Outcomes

What outcomes has the University of Illinois Medical Center experienced since

implementing their full disclosure process? The results have been positive:

 Families who have experienced an error or an adverse outcome at the University

of Illinois Medical Center continue to seek care there That includes the case they settled for a large amount

 Patient safety has improved As McDonald says, “Each and every one of our caseshas its own associated process improvements and we’re tracking them all We

Remedies

“We meet with patients, apologize, and provide a remedy whether patients want to file a claim or not,” says McDonald “The first important case in which we put our policy and process into practice involved the unfortunate death of a young patient,” McDonald recalls “Within 90 days,” he says, “we settled the case for a large amount We’ve had many other, smaller cases in which remedies ranged from waiving a small hospital fee,

to $75,000 We have waived fees for professional services, hospital and other medical services, drug costs, and more These are real remedies and they impact the lives of our patients.” McDonald explains their centralized hospital and professional billing offices have the ability to put a hold on billing of the patient in case of an error or a potential error

have been able to show through root cause analysis, for example, that the failure

to supervise residents led to many medical errors With our new process there has been greater engagement by attending physicians with resident physicians, and education and supervision on patient safety-related issues.”

 The time it takes for clinicians to receive critical test results and to communicate those results to patients has been reduced

 Employee attitudes have improved “People are glad to finally be in an

organization in which clinicians can openly disclose errors in an organized way and offer remedies to patients and families when appropriate,” says McDonald

Lessons Learned

McDonald shares the following lessons learned:

 Persuade your lawyers that disclosing medical errors is the right thing to do ethically, legally, and financially, despite their fears related to admitting liability

 Recognize that shifting the culture of an organization is not easy and takes time

 Get buy-in from all the stakeholders once you decide on a process

University of Michigan Health System

The University of Michigan always considered itself ethical and open with its patients about mistakes and patient injuries, but in 2001 it systematically began to initiate

conversations with patients who complained and threatened to sue To Rick Boothman, Chief Risk Officer, open disclosure first made common sense as a way to save money: if you knew you made an error and would have to settle anyway, wouldn’t it make more sense simply to admit the error and compensate patients, saving hundreds of thousands ofdollars in court costs and attorneys’ fees?

But for Boothman and his colleagues, what started out as a pragmatic approach to

managing claims soon became much more “There is no question in my mind that the culture of open disclosure paves the way for clinical improvement in ways that we have never seen before,” Boothman explains “The culture of deny-and-defend prevents us from improving Being open with patients starts with being honest with ourselves about our failings—that is a necessary prerequisite to any real improvement That is where the real gold lies,” he says

Guiding Principles

There are three principles that guide the University of Michigan Health System’s

approach to a claim of medical error:

 They compensate patients and families when they’ve made an error

 They fight to defend themselves when their care was reasonable

 They systematically use mistakes as tools for learning and for making needed changes to their system.

“When we make an error,” Boothman says, “we do not hesitate to accept responsibility, apologize directly to the patient, and move quickly to compensate them without their having to file a malpractice suit But when we think our care was reasonable, we explain

to the patient and family, and their lawyers, why we don’t think they have a case,”

Boothman says

Boothman spent much of his time that first year meeting with medical staff, faculty, University of Michigan trial attorneys, the courts, and the plaintiff’s bar in Southeastern Michigan to explain and gain acceptance for this approach In his meetings with

plaintiff’s attorneys, Boothman presented the essence and significance of this new

approach: he explained the University of Michigan’s commitment to compensate quickly and fairly when they felt the medical care was unreasonable, but he cautioned that they would defend their staff and institution vigorously when they felt the care was

reasonable He committed to working with plaintiff’s attorneys so they would understandthe difference between reasonable and unreasonable care before litigation was filed

What enabled Boothman to take this unusual approach in response to medical errors?

“Leadership and faith that we were doing the right thing,” Boothman says “There are corporate cultures in every organization Some cultures will make this easier to do than others For some, deny, defend, and scorched earth is the way they choose to do things It’s tougher to get those organizations to say, ‘Maybe we did make a mistake and maybe

we ought to be courageous enough to confront it and tell people that.’ I happen to be blessed with an institution that has an historically open culture and medical leadership in the form of Skip Campbell, chief of staff, who is unflinching about patient safety and honesty,” Boothman says

The Process

Michigan laws have created the ideal circumstances for Boothman’s approach The University of Michigan Health System takes advantage of the compulsory six-month pre-suit notice period the law allows (Michigan Compiled Law 600.2912) Before a

malpractice suit may be filed against any health care practitioner or facility in Michigan, the patient or patient’s family is required, by law, to present details of their claims in writing Once this notice is served, a suit cannot be filed for 182 days This pre-suit noticeperiod allows prospective defendants time to investigate the claim, gives them the

opportunity to meet with the patient or family, and offers patients and families time to reconsider their decision to sue

The University of Michigan Health System strives to thoroughly review the required written claims within three months or less (see Figure 1) Every suspected injury and claim is triaged and a focused investigation planned Each case undergoes internal and, often, external expert reviews The patient care at issue is submitted to the Medical Liability Review Committee, which reaches conclusions about the reasonableness of the

care delivered and its impact on the patient’s outcome The committee also considers every submitted case for peer review, clinical quality improvement, and educational opportunities The committee’s role is purposefully restricted to medical issues and quality of care concerns Its conclusions inform claims management, but this committee does not oversee litigation or involve itself in the financial aspects of claims

management

Figure 1

Once the issues have been clarified, the University of Michigan Health System openly discusses them with the patient and his or her lawyer Often, patients and lawyers are invited to meet with the doctors or nurses they are threatening to sue, or with experts whose opinions are pivotal to the assessment Discussions usually occur between the Chief Risk Officer or a Risk Management consultant and the patient and his or her lawyer This disclosure is vital to the success of the program: parties have a chance to reconcile their recollections and analyses about the patient’s care and complaints

Questions are answered Factual information is supplied and misinformation corrected Other perspectives are communicated and explored Expert reviews are shared

Frequently, patients and their lawyers are satisfied with the explanations and neither suit nor settlement follows

If the Medical Liability Review Committee concludes the care was unreasonable and the patient’s outcome suffered, and the patient is interested in compensation, there is an

attempt at resolution In some cases, discussions are extended by agreement to offer the parties more time to explore the issues In one case, for example, a patient suffered an errant nerve transection that was grafted An interim payment was made to help the patient with his immediate business needs, and the parties regrouped 14 months later to evaluate the outcome of his nerve repair.

The University of Michigan Health System’s commitment to its principles opens the door

to immediate and decisive quality improvement measures and peer review opportunities Fear of adversely impacting subsequent litigation is virtually non-existent because the University of Michigan Health System is committed to acting consistently with its own conclusions about the reasonableness of care Unfettered by fear of litigation, patients’ complaints travel through a process designed to prompt all involved to ask whether the care could have been better, whether anything can be done to avoid such complaints in the future, and whether there are lessons to be learned (See Figure 2.)

Figure 2

Barriers to Full Disclosure

The biggest barriers to implementing their full disclosure policy were, first, the

perception that openly disclosing medical errors would adversely impact the health system’s ability to defend itself and, second, according to Boothman, those within the university who still worry about adverse consequences of open disclosure Fear of

lawsuits and fear of disclosing medical errors to irate patients and their families can be powerful deterrents to doctors Despite the logic and common sense of Boothman’s

approach—and despite the positive outcomes that have resulted—“lawyers who tell

clients to deny and defend find a willing audience because doctors’ emotions rather than logic are guiding them,” Boothman says “This is a battle we’re making progress on, case

by case, doctor by doctor We’ve had to overcome the human impulse to avoid anything we’re sure is going to be uncomfortable or distasteful,” he says

Overcoming the Barriers

Boothman has found the most effective way to overcome the barrier of fear is to remind doctors that full disclosure serves the best interests of the doctor and the institution

“But,” he says, “this is an intellectual argument that has to overcome the emotional

reticence of doing this You’ve got to be able to say to a doctor, ‘I serve you best by

helping you avoid litigation And if we made a mistake, the best way to avoid litigation is

to make it right, right now.’”

The second argument that helps to overcome the barriers is to remind doctors that it is only by confronting and thoroughly investigating an error that clinical improvement is possible “And the faster we do this while the lessons are still fresh, the better,”

Boothman says

Outcomes

Reassuring Patients and Doctors

“There was a case in which a University of Michigan doctor had not made an error, but there was a delay in diagnosing a woman’s breast cancer,” Rick Boothman says He continues, “I told the oncologist, whose care was not at issue, that we needed to

understand the implications of this delay: did it make a difference in her care, did it make

a difference in her prognosis, would she need to have surgery when she might otherwise not have needed surgery? I explained that I wanted him to talk openly to the patient and her lawyer and simply tell them what he’d already told me Despite the fact that his own care was not being questioned, his response was, ‘I’d rather eat tacks.’ I finally asked him

to trust me That case settled two days after we had the meeting And to this day the patient will tell you that conversation made all the difference for her She found it

reassuring, she found it honest.”

After this physician’s experience with open communication, Boothman says, “I think he’s

a convert He understands But he also appreciates the level of support and skill we provide We prepare people well We don’t script it for them, but we help reassure them and help them understand what the themes ought to be They’re often worried a patient will become very confrontational One of the first things I tell them is, ‘If this ever gets uncomfortable, it’s totally voluntary; we’ll just stop it.’ It’s never happened, but that’s always a concern.”

Like the other organizations in the early stages of implementing processes for disclosing medical errors, Boothman is reluctant to attribute their declines in malpractice suits since

2001 to their new policy; other factors are always in play “The malpractice climate is affected by so many things,” he says, “social forces, the political climate, statutory changes I have been told that patients and lawyers have walked away from suits they otherwise would have brought, but I do not know whether this is directly attributable to our policy.”

That being said, Boothman continues, “We’ve experienced a reduction in claims that has exceeded anyone’s expectations.” “Certainly,” he adds, “our full disclosure policy hasn’t been the catastrophe everyone predicted it would be.” The number of claims against the health system has dropped steadily since 2001

Of course, the number of malpractice suits is not the only measure of their policy’s effectiveness Another measure is physician satisfaction with the process and the

outcome “I believe we’ve tapped into something physicians intrinsically want to do, anyway,” Boothman says, “but have been afraid to do and have been told not to do for their entire careers.” Doctors feel empowered by the policy because they finally have permission to tell the truth

Their full disclosure policy has also created a culture in which clinicians understand and value the importance of communicating with patients, regardless of whether an error has occurred “Disclosure has to start from the very beginning of the patient’s care If the patient’s experience is close to what they’ve been led to expect it would be, then

everything, even after a complication occurs, is a heck of a lot easier to manage,”

Boothman says

“Most importantly,” Boothman says, “our policy of disclosure has clearly energized the patient safety efforts here because it’s not taboo to talk about errors openly and to openly express opinions We’re seeing a willingness to confront these issues on a departmental and an institutional level I think that would be impossible in a culture of deny-and-defend.”

Lessons Learned

Boothman shares the following lessons he and his colleagues have learned since

implementing their full disclosure policy:

 Don’t expect leadership to embrace this unquestioningly Start with small

successes and publicize them widely to gain the confidence of leadership

 Have courage It is important to appreciate the significance of what you’re asking people to do, especially because it runs contrary to human nature

 Be willing to hold the line both ways Sometimes you need to tell patients they won’t be compensated because your care was reasonable; sometimes you need to tell doctors they made an error and must communicate that to patients and their families

Virginia Mason Medical Center

Open communication, including timely and transparent communication about medical errors to patients and families, has been part of Virginia Mason Medical Center’s culture since its founding in 1920, according to Cathie Furman, R.N., M.H.A., Senior Vice President of Quality and Compliance Now, they wanted to do more than communicate errors: they wanted to prevent them They looked to the automobile manufacturing industry for a model Why cars? Because, Furman says, “Both automobile manufacturingand health care must produce a safe product or people die.”

In 2001, Furman and her colleagues went to Japan to see what Toyota was doing to prevent product errors During what she calls a “life-changing” visit, they learned that open communication throughout the organization is key to mitigating real and potential errors Toyota’s principles, they believed, could be applied just as effectively to health care Furman and her colleagues decided to put Toyota’s principles into practice at

Virginia Mason “In Toyota’s pursuit of zero defects,” Furman explains, “we saw that anyworker at any time could stop this multi-million dollar line if they saw a quality defect or error We thought, ‘If they’re able to do this for cars, we should certainly be able to do this for our patients.’” In 2002, they introduced the “Virginia Mason Patient Safety Alert System,” the pursuit of zero medical errors Adopting the Patient Safety Alert System was

an executive decision at the top level of the organization, according to Furman “The leadership of Virginia Mason declared, ‘This is how we’re going to do our business,’” shesays

The Virginia Mason Patient Safety Alert System

“An ingredient of the Toyota production system is transparency and visibility,” Furman explains “We began to look at how transparent we were,” she says, “and realized we weren’t as transparent as we could be.” Their solution to this problem was to develop their Patient Safety Alert System, which declares the following principles:

 Everyone is considered a safety inspector Anyone from the housekeeping staff on

up can and should “stop the line” if they see a patient safety issue by reporting it, according to Furman “This is a big deal in health care because health care is very hierarchical,” Furman admits “For us or any health care organization to tell a

housekeeper or a patient care technician that we want them to tell us if they see an unsafe situation—if a doctor or nurse is not following policy, for example—that’s a big deal,” she explains

 When anyone reports a patient safety concern, the process stops immediately

“When the incident is reported, we determine whether we should pull the process and provider off-line during our investigation We don’t want even one more patient to be exposed to whatever that process error might be and we’ve completed an

improvement plan,” Furman says

 “Poka-yoke,” the Japanese term for mistake-proofing “Before any ‘red’ patient

safety alert can be closed—and they all go to the board for closure—we need to demonstrate that we’ve done something to ensure that the error never happens again,”says Furman

Virginia Mason’s patient safety alerts are color-coded, the colors reflecting whether there was actual harm or potential harm “We’re required to complete an investigation of actualharm to a patient involving permanent or close to permanent damage within 24 hours If it’s a near-miss, our investigation will take longer, perhaps a week,” Furman says

Patient safety alerts can be reported anywhere, by anyone in the organization, by

telephone or through the Internet “A scrub technician can ‘stop the line’ in the operating room when a surgeon doesn’t take the procedural pause We’ve also had reports about elevators malfunctioning and outdated tuna sandwiches,” she says

When Mary McClinton died in November 2004 after receiving an injection of

chlorhexidine instead of normal saline, Virginia Mason communicated the error

throughout the entire organization as well as to the family “Because our culture had gotten to the point where we were very transparent—and because we knew this caustic solution was present in the organization, but we didn’t know who was using it and to what degree—we sent an e-mail out to all 5,000 of our employees telling them what happened An investigation started and we changed our policy about the use of these solutions that day,” Furman relates “We felt we owed it to our patients.” The hospital also provided information about this medical error to the media and in this way other hospitals were able to learn from their mistake “Other hospitals were able to correct theirprocesses for the use of this solution as a result of our disclosure,” she says

The Importance of Training

Virginia Mason’s focus on error prevention runs parallel to their focus on the need to provide continual training for physicians in how to effectively communicate errors to patients and families

Virginia Mason offers two-and-a-half-hour workshops each year to teach physicians how

to communicate medical errors and unanticipated events to patients and families

Training is not mandatory, Furman says, but word of mouth has spread and physicians want to attend “We send invitations to physicians telling them they’ve been selected as someone who could really use this training First, we invite the high-risk physicians for training: the intensivists, the hospitalists, and the surgeons, since they’re the ones who aremost likely to need this service, as opposed to primary care physicians,” she says

In addition to training individual clinicians, Virginia Mason has developed the role of the

‘situation facilitator,’ according to Furman, “12 people who have a deep knowledge abouthow to communicate errors.” Situation facilitators undergo two full days of training Once they are trained, physicians must consult them whenever an error needs to be disclosed

“One hundred percent of Virginia Mason’s physicians know they must call the Patient Safety Alert System to report an error or a potential error,” Furman says Situation

facilitators take physicians’ calls, ask them how they plan to communicate the problem to the patient or family, and then advise them about the need to have a situation facilitator present when this discussion takes place

Challenges

Virginia Mason still faces challenges in their pursuit of open, transparent communication

of medical errors As Furman says, these challenges include the following:

 Lack of clarity in some situations about what constitutes an error and what is an event that can be considered normal during the course of care “For example, infections,” she says “Is this an infection we gave to the patient, or is this an infection caused by the patient’s compromised immune state? Is it an error or a natural outcome of a person’s disease? When the answer is unclear, we tell the patient, ‘This is what’s going on, but we’re not certain what the cause is.’” As soon as their investigation reveals the cause of the adverse outcome, they

communicate their findings to the patient

 Virginia Mason now receives so many reports through their Patient Safety Alert System that they need to channel their resources and prioritize their handling of cases “For example,” says Furman, “our Chief Nursing Officer can have five patient safety alerts actively open She needs to decide which ones to manage at any particular moment.” Circumstances that result in patient harm are always handled first

 Since their Patient Safety Alert System began, Virginia Mason has had more than 6,000 reports

“Because people are reporting more freely,” Furman continues, “we’re able to learn what the problems are.” Learning what the problems are allows Virginia Mason to

communicate them to patients and families quickly and accurately, to fix them, and to take steps to ensure they never happen again

Virginia Mason has also tracked malpractice claims, Furman says “It looks as though we have had fewer claims over last few years,” she says, but cautions they cannot make

simple comparisons of the dollar amounts paid to plaintiffs or attribute the cause to their Patient Safety Alert System.

again, I would put more effort into raising everyone’s awareness,” she says

 “Tell stories and overcome fear by being transparent For example, we’d tell stories at our monthly meetings about how we pulled doctors off the line and they couldn’t work because they shouted at a nurse This was important to nurses who were afraid to challenge certain doctors These stories helped them overcome theirfear.”

 “You just have to do it Too many physicians and other staff are afraid and have excuses Our patients and their families want to know what we’re doing to correcterrors and make sure they don’t happen again.”

Kaiser Permanente

Patient safety is every patient's right and every leader’s, employee’s, and clinician’s

responsibility Patient care should be reliable, effective, and safe Kaiser Permanente is committed

to an ongoing and relentless effort to build safer systems Yet, despite constant and committed efforts

to provide safe health care, from time to time patients experience unanticipated outcomes that are adverse

To fulfill our commitment to our patients, “Quality You Can Trust,” we embrace our

responsibility and acknowledge our ethical obligation to communicate with our patients when an unanticipated adverse outcome has occurred When such an outcome occurs, the patient, or the patient’s health care representative, has a right to an explanation of the outcome and its effects, provided in a timely, truthful, and compassionate manner.

Human error and systems conditions periodically align and combine to contribute to

unanticipated adverse outcomes for patients What is most important is the manner in which we handle these circumstances Patient safety and clinician welfare will be best served if we are honest about unanticipated adverse outcomes with our patients, open with our colleagues and ourselves, and able to handle such occurrences with sympathy and empathy for our patients and our colleagues

Kaiser Permanente is a pre-paid, group practice, nonprofit integrated health care delivery system with facilities concentrated in northern and southern California, the mid-Atlantic and Northwest regions of the United States, Georgia, Ohio, Colorado, and Hawaii

The 1999 Institute of Medicine (IOM) report, To Err Is Human, 5 caused Kaiser to

re-examine how it was communicating with patients and families when something went

wrong in their care, according to Doug Bonacum, Vice President for Safety Management,the Kaiser Foundation “The IOM report said that health care needs to hold itself

accountable and be transparent and sympathetic with patients and their families in the

wake of unanticipated adverse outcomes,” says Bonacum The IOM report prompted

senior management at Kaiser to ask, ‘How well are we doing that? What could we be

doing better?’”

“Kaiser felt an ethical obligation to have open discussions with patients and families

when we contribute to patient harm because it is aligned with our values,” says Bonacum.Once they recognized the need for such discussions, Kaiser developed and disseminated apolicy statement about what Kaiser expects its physicians to do in the wake of a patient injury They trained physicians to have open disclosure conversations with patients and families, established peer support groups, and developed ways to foster continuing

dialogue until the patient and family feel their needs have been met

5 Institute of Medicine To Err Is Human: Building a Safer Health Care System Washington, DC: National

Academies Press, 1999.

Guiding Physicians

The first thing Kaiser did, according to Bonacum, was to develop and disseminate a step statement of principle to guide physicians in communicating with patients and their families in the aftermath of an adverse outcome or medical error:

six- Step 1: Care for the Patient The first priority in responding to an unanticipated

adverse outcome is to address the current health care needs of the patient by assessing the patient’s condition and determining what, if anything, needs to be done immediately

 Step 2: Communicate about the Unanticipated Adverse Outcome After caring

for the patient’s immediate clinical needs, preparation for the initial

communication session with the patient and/or the patient’s representative must begin This session should address the “who, what, when, where, and why” surrounding the unanticipated adverse outcome A lead coordinator should be designated to manage the communications

 Step 3 Report to Appropriate Parties Various people, departments, entities, or

agencies may need to be notified that there has been an unanticipated adverse outcome Internal notification and reporting should be conducted in accordance with a facility-specific Situation Management Plan

 Step 4 Check the Medical Record The medical record should contain a

complete, accurate record of clinical information pertaining to the unanticipated adverse outcome As applicable, this should include:

o Objective details of the situation, written in neutral, non-judgmental language;

o The patient's condition immediately prior to the event;

o The intervention and patient response;

o Notification of the primary care physician and attending physician; and

o Information shared with the patient and/or patient’s representative

following the event

 Step 5 Follow Up and Provide Closure The ongoing goal in the aftermath of an

adverse event is to meet the patient’s health care needs and concerns and to help manage and address the patient’s and/or patient representative's emotional needs

It is critical to assume the burden of maintaining open communication After the initial discussion and throughout the event analysis, it may be necessary and appropriate to conduct follow-up discussions to:

o Convey new information discovered and corrective action taken;

o Maintain an ongoing dialogue regarding patient care issues; and

o Identify and address new concerns of the patient and/or patient’s

representative